- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in collaboration with the CRO and the study team. Oversee the site qualification process . Monitor clinical trial performance and quality metrics and share ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...safety communications, DSUR, IND.Lead the CRO and vendor selection process in collaboration with the study team and outsourcing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centers globally in partnership with other cross-functional leaders.- Contribute to Clinical Development initiatives, global education, and process development ... process improvement, Protocol review, training, SOP development, other Clinical (oncology) Development line function initiatives) and represent the function on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the required functions, in regions and countries for all GOMA clinical activities. Process /Policies/Compliance Provide input to process standards ... disorders. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in...(MAP)/(EAP)Support the oversight of the overall global oncology review process of PhIV company sponsored studies per the Standard… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical questions from sites/ ... and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy, design,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy, design, ... execution, and interpretation of Oncology clinical trials. Position Summary / Objective Serves as a...are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):- Provides oversight to the CRO MM for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively identifies compliance ... the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs, external publications, and regulatory authority submissions (IMPD/IND)… more
- Aequor (Seattle, WA)
- …experience as a technical writer or in a related role within a clinical laboratory or regulated environment. We are seeking a highly skilled and detail-oriented ... Technical Writer to join our dynamic clinical laboratory team. The ideal candidate will be responsible for creating, reviewing, and maintaining comprehensive and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …In conjunction with the Director of Data Stewardship, Cataloging and Process , develop implement a data stewardship community and set of practices ... strategies for cleansing and standardizing data, with a focus on eg, clinical , product, and vendor data and Identify and rectify data anomalies, inconsistencies,… more
- Merck & Co. (North Wales, PA)
- …reports to ensure standardization and optimization from both a system and process prospective.Assist in preparing and responding to Regulatory Agency Inspections as ... well as internal and external audits.Lead efforts to improve departmental efficiencies. Monitor metrics are tracked to demonstrate compliance with PV regulation and… more
- Eisai, Inc (Louisville, KY)
- …utilization of promoted Oncology therapeutic products for specific indications; deliver clinical , efficacy, and safety messaging to target physicians in a compliant ... / safe administration by working with appropriate Health Care Providers. Complete ongoing clinical acumen and compliance training with goal of being expert level for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as in the Alliance) for company sponsored and externally sponsored research- Monitor the consistency of IEP process across all asset teams in ... collaboration with other EG Sr Directors, propose the process modifications and lead the implementation across the asset teams.- Provide functional excellence expert… more
- Lundbeck (Stamford, CT)
- …our psychiatry portfolio, executing sales and marketing strategies with comprehensive clinical knowledge to drive sales performance. Our Account Managers are adept ... develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of oncology, with a deep understanding of the drug discovery and development process , clinical trials, and regulatory requirements. TravelAbility to travel up to ... developing, implementing, and ensuring adoption for Generative AI solutions process , from data acquisition and pre-processing to training and deployment… more
- Eisai, Inc (San Diego, CA)
- …utilization of promoted Oncology therapeutic products for specific indications; deliver clinical , efficacy, and safety messaging to target physicians in a compliant ... / safe administration by working with appropriate Health Care Providers. Complete ongoing clinical acumen and compliance training with goal of being expert level for… more
- Merck & Co. (South San Francisco, CA)
- …and licensing opportunities to capitalize on novel insights and complement internal pipeline. Monitor emerging biology and basic & clinical research within ... to direct reports and peers.Solid understanding of drug discovery and clinical development.Working knowledge of biomarker discovery, translational research, and data… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on a modified second shift. This ... requirements. This individual will support the organization in its build and ramp-up of clinical production and facility approval of a state of the art cell therapy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …US market access input to Global and US stakeholders to inform clinical trial programs, guide evidence generation development, payer value stories, and develops ... of cell therapy reimbursement. Shape the payer value story, supported by credible clinical , health economics and quality of life messages as the market and the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes managing ... nonconformances.Lead the daily touch point meetings with the team and monitor workload.Lead the daily triage meeting for nonconformance initiation.Support the… more
- Lundbeck (El Paso, TX)
- …Skilled Nursing Facilities.You will drive demand creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the local ... develop strategy & tactics, allocate resources to enhance sales execution, monitor progress and adjust direction to maximize sales performance. Selling -… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Lead is responsible for supporting the therapeutic area One Impact Planning process , ensuring strategic alignment and consistent therapy area vision / messaging ... Analytic-Driven Optimization: Utilize data analytics to provide data-driven insights, monitor and evaluate the performance of therapeutic area operations, and… more
